Head of Regions Quality Management and Regulatory Affairs

Siemens Healthineers

6d•$240,000 - $330,000•Remote

About The Position

Lead the Regional Quality & Regulatory Affairs organization across North America, EMEA, APAC, and Latin America, driving a harmonized, standardized, and high-performing operating model that ensures regulatory compliance, product safety, and operational excellence across Commercial Operations and Customer Services. Serve as the Regional Head of Quality & Regulatory Affairs for North America, ensuring compliance, product quality, and business continuity across commercial operations and customer services. Develop and execute regional Quality & Regulatory strategies, translating regulatory requirements into pragmatic business actions that enable market access, customer satisfaction, and sustainable growth. Act as the Quality Representative for assigned legal entities, fostering a risk-based quality culture that balances regulatory compliance with business objectives.

Requirements

15+ years in Quality and/or Regulatory Affairs within medical device / pharma, including leadership responsibility.
Strong experience with QMS, regulatory submissions/approvals, inspections (e.g., FDA/NMPA), and product safety/compliance frameworks.
Proven success leading Quality & Regulatory organizations in complex, international matrix environments.
Experience driving global process harmonization, standardization, and implementation of Quality Management Systems across multiple countries and cultures.
Degree in Life Sciences, Engineering, or a related discipline.
Deep expertise in Quality & Regulatory frameworks, including QMS, audits, and authority interactions.
Ability to translate regulatory requirements into clear business actions and decisions.
Strong analytical, data-driven, and problem-solving mindset.
Effective stakeholder management and communication in global, cross-functional settings.
Proven ability to lead, develop, and drive performance of high-performing teams.
High ownership, execution focus, and change agility.
Fluent in English.

Responsibilities

Lead and develop the Regional Quality & Regulatory leadership teams across EMEA, APAC, and Latin America, driving capability, accountability, and performance.
Establish a harmonized global operating model by standardizing Quality & Regulatory processes, governance, tools, and best practices across all regions.
Drive consistency in Quality Management Systems, regulatory execution, performance metrics, and continuous improvement while enabling appropriate regional flexibility.
Foster cross-regional collaboration, knowledge sharing, and operational excellence to improve efficiency, compliance, and customer outcomes.
Maintain and continuously improve the Quality Management System (QMS) to meet regulatory and business requirements.
Ensure effective execution of Quality Assurance and Quality Engineering processes (e.g., audits, training, documentation, CAPA, nonconformance management).
Identify and mitigate quality risks in commercial operations through structured risk management.
Drive process improvements that increase efficiency, product quality, and customer satisfaction.
Leverage digital tools and data insights to enhance quality performance, transparency, and decision-making.
Define and execute the regional regulatory strategy, ensuring timely submissions, approvals, and adherence to country-specific requirements.
Ensure full compliance with internal policies and external regulations, with a strong focus on product safety and market access.
Translate regulatory requirements into clear business implications and actionable guidance for leadership teams
Act as key interface to health authorities and external stakeholders, representing the organization with credibility and impact.
Ensure product integrity and compliance across commercial operations and customer services.
Ensure on time and accurate Post Market Surveillance & Reporting
Partner with customer-facing teams to resolve quality issues and improve the end-to-end customer experience.
Embed a strong quality culture focused on continuous improvement and customer-centricity.
Build and lead a high-performing regional Quality & Regulatory team, driving accountability, capability, and ownership.
Collaborate closely with global Quality and cross-functional teams to align standards, share best practices, and ensure consistent execution.